U.S. patent number 9,345,507 [Application Number 14/453,254] was granted by the patent office on 2016-05-24 for systems and methods for treatment of bph.
This patent grant is currently assigned to NXTHERA, INC.. The grantee listed for this patent is NXTHERA, INC.. Invention is credited to Michael Hoey, John H. Shadduck.
United States Patent |
9,345,507 |
Hoey , et al. |
May 24, 2016 |
Systems and methods for treatment of BPH
Abstract
A prostate therapy system is provided that may include any of a
number of features. One feature of the prostate therapy system is
that it can access a prostate lobe from the urethra. Another
feature of the prostate therapy system is that it can deliver
condensable vapor into the prostate to ablate the prostate tissue.
Another feature of the prostate therapy system is that it can
aspirate tissue from the prostate. Yet another feature of the
prostate therapy system is that it can rotate during delivery of
vapor and aspiration of tissue. Methods associated with use of the
prostate therapy system are also covered.
Inventors: |
Hoey; Michael (Shoreview,
MN), Shadduck; John H. (Menlo Park, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
NXTHERA, INC. |
Maple Grove |
MN |
US |
|
|
Assignee: |
NXTHERA, INC. (Maple Grove,
MN)
|
Family
ID: |
42153271 |
Appl.
No.: |
14/453,254 |
Filed: |
August 6, 2014 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20150025516 A1 |
Jan 22, 2015 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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13764645 |
Feb 11, 2013 |
8801702 |
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12614226 |
Feb 12, 2013 |
8372065 |
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61112103 |
Nov 6, 2008 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B
17/32056 (20130101); A61B 18/04 (20130101); A61B
17/3203 (20130101); A61B 17/32037 (20130101); A61B
18/1485 (20130101); A61B 2018/00547 (20130101); A61B
2017/22067 (20130101); A61B 2018/048 (20130101); A61B
2017/00274 (20130101); A61B 2017/32035 (20130101); A61B
2018/0063 (20130101); A61B 2017/22079 (20130101); A61B
2018/00577 (20130101) |
Current International
Class: |
A61B
18/04 (20060101); A61B 17/3203 (20060101); A61B
17/3205 (20060101); A61B 18/14 (20060101); A61B
17/00 (20060101); A61B 17/22 (20060101); A61B
18/00 (20060101) |
Field of
Search: |
;606/27,41
;607/104,105,113 ;604/113,22,500,517 |
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Primary Examiner: Ram; Jocelyn D
Attorney, Agent or Firm: Shay Glenn LLP
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No.
13/764,645, filed Feb. 11, 2013, now U.S. Pat. No. 8,801,702, which
is a divisional of U.S. application Ser. No. 12/614,226, filed Nov.
6, 2009, now U.S. Pat. No. 8,372,065; which application claims the
benefit under 35 U.S.C. 119 of U.S. Provisional Patent Application
No. 61/112,103, filed Nov. 6, 2008, titled "Systems and Methods for
Treatment of BPH." These applications are herein incorporated by
reference in their entirety.
Claims
What is claimed is:
1. A method of treating a patient's prostate comprising:
introducing a vapor energy delivery system into a urethra of the
patient; rotating the vapor energy delivery system within the
urethra; delivering a flow of fluid through at least one hypotube
of the vapor energy delivery system; inductively heating the at
least one hypotube to generate a condensable vapor from the flow of
fluid; and delivering the condensable vapor from the vapor energy
delivery system to the patient's prostate.
2. The method of claim 1 further comprising expanding an occlusion
member within the urethra distal to a tissue extraction member
vapor exit port prior to the delivering step.
3. The method of claim 1 further comprising expanding an occlusion
member within the urethra proximal to a tissue extraction member
vapor exit port prior to the delivering step.
4. The method of claim 1 wherein the rotating step comprises
rotating the vapor energy delivery system between 5 rpm and 10,000
rpm.
5. The method of claim 1 wherein the rotating step comprises
manually rotating the vapor energy delivery system.
6. The method of claim 1 wherein the rotating step comprises
rotating the vapor energy delivery system with a powered rotating
motor.
7. The method of claim 1 further comprising aspirating prostate
tissue into the vapor energy delivery system.
8. The method of claim 7 wherein the aspirating step comprises
removing between 10 grams and 50 grams of prostate tissue from the
prostate.
9. The method of claim 7 further comprising heat sealing tissue
margins around the aspirated prostate tissue.
10. The method of claim 1 wherein delivering condensable vapor
comprises delivering between 100 W and 1000 W to the prostate.
11. The method of claim 1 wherein delivering condensable vapor
comprises delivering between 100 cal/gram and 600 cal/gram to the
prostate tissue.
12. The method of claim 1 wherein the introducing step further
comprises transurethrally introducing the vapor energy delivery
system into the urethra.
Description
INCORPORATION BY REFERENCE
All publications and patent applications mentioned in this
specification are herein incorporated by reference to the same
extent as if each individual publication or patent application was
specifically and individually indicated to be incorporated by
reference.
FIELD OF THE INVENTION
The present invention relates to an apparatus and a related method
for the minimally invasive treatment of prostate tissue.
BACKGROUND OF THE INVENTION
Several systems and methods have been developed or proposed for the
treatment of prostate tissue to alleviate BPH symptoms or to treat
prostate tissue. For example, tissue ablation methods have been
based on RF ablation, microwave ablation, high intensity focused
ultrasound (HIFU), cryoablation, radiation, surgery, and
brachytherapy. Surgical methods with and without robotic assistance
have been developed for removal of diseased prostate tissue.
The apparatus, techniques and methods disclosed herein are adapted
to for the treatment of prostate tissue in general and more
particularly are focused on treatment of BPH (benign prostatic
hyperplasia) and prostate cancer. BPH is a common problem
experienced by men over about 50 years old that relates to urinary
tract obstruction. Prostatic hyperplasia or enlargement of the
prostate gland leads to compression and obstruction of the urethra
which results in symptoms such as the need for frequent urination,
a decrease in urinary flow, nocturia and discomfort.
Ablation of prostatic tissue with electromagnetic energy is well
known and has the advantage of allowing a less invasive approach.
For example, high-frequency current in an electrosurgical ablation
or prostatic tissue causes cell disruption and cell death. Tissue
resorption by the body's wound healing response then can result in
a volumetric reduction of tissue that may be causing urinary tract
obstruction. One disadvantage of high-frequency current or laser
ablation is potential tissue carbonization that results in an
increased inflammatory response and far longer healing time
following the ablation.
SUMMARY OF THE INVENTION
A method of extracting tissue from a patient's prostate is
provided, comprising, introducing a tissue extraction member into a
urethra of the patient, rotating the tissue extraction member
within the urethra, injecting condensable vapor from the tissue
extraction member, and aspirating prostate tissue into the tissue
extraction member.
In some embodiments, the method further comprises injecting high
pressure liquid from the tissue extraction member into the urethra.
The high pressure liquid can be injected in pulses between 1
pulse/second and 100 pulses/second. In some embodiments, the high
pressure liquid is injected radially outward from a longitudinal
axis of the tissue extraction member. In other embodiments, the
high pressure liquid is injected at an angle of between 10 degrees
and 90 degrees from a longitudinal axis of the tissue extraction
member.
The method can further comprise expanding an occlusion member
within the urethra distal to a tissue extraction member vapor exit
port prior to the injecting step. The method can further comprise
expanding an occlusion member within the urethra proximal to a
tissue extraction member vapor exit port prior to the injecting
step.
In some embodiments, the rotating step comprises rotating the
tissue extraction member between 5 rpm and 10,000 rpm. The tissue
extraction member can be manually rotated, or can be rotated with a
powered rotating motor.
In some embodiments, the method further comprises heat sealing
tissue margins around extracted tissue in the prostate.
In one embodiment, injecting condensable vapor comprises delivering
between 100 W and 1000 W to the prostate. In another embodiment,
injecting condensable vapor comprises delivering between 100
cal/gram and 600 cal/gram to the prostate.
In some embodiments of the method, the aspirating step comprises
removing between 1 gram and 100 grams of prostate tissue from the
prostate.
A prostate therapy system is provided comprising a condensable
vapor source, and a tissue extraction member adapted to be inserted
into a urethra of an adult male human subject and to rotate within
the urethra, the tissue extraction member having a vapor delivery
port communicating with the vapor source and adapted to deliver
condensable vapor to the prostate lobe and an aspiration port
adapted to aspirate prostate tissue proximally into the ablation
probe.
The tissue extraction member can further comprise a liquid ejection
port communicating with a source of high pressure liquid. In some
embodiments, the liquid ejection port and high pressure liquid
source are adapted and configured to eject high pressure liquid in
pulses between 1 pulse/second and 100 pulses/second. The liquid
ejection port is adapted and configured to eject high pressure
liquid radially outward from a longitudinal axis of the tissue
extraction member. In some embodiments, the liquid ejection port is
adapted and configured to eject high pressure liquid at an angle of
between 10 degrees and 90 degrees from a longitudinal axis of the
tissue extraction member. In one embodiment, the liquid ejection
port is concentric with the vapor delivery port.
The prostate therapy system can further comprise a distal occlusion
member adapted to occlude the urethra distal to the vapor delivery
port, and a proximal occlusion member adapted to occlude the
urethra proximal to the vapor delivery port.
In some embodiments, the prostate therapy system further comprises
a powered rotating motor configured to rotate the tissue extraction
member between 5 rpm and 10,000 rpm.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a vapor energy delivery system and more particularly a
cut-away view of a handle portion of an instrument with an
inductive heating assembly for applying vaporization energy to a
fluid flow together with a looped flow system for maintaining a
circulating flow of high energy vapor which is releasable on demand
to flow through an extension member to interact with tissue.
FIG. 2 is a schematic view of the inductive heating assembly of
FIG. 1.
FIG. 3 is a schematic view of a patient prostate and a first step
of introducing a tissue extraction member into a patient urethra,
showing tissue volumes targeted for extraction.
FIG. 4 is a perspective view of an instrument working end.
FIG. 5 is a sectional view of the working end of FIG. 4
illustrating schematically how tissue is extracted and sealed.
FIG. 6 is a schematic view of another instrument working end.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides for a vapor energy generation system
that can be configured for introduction into a patient's urethra or
prostate, or can be configured to access prostatic tissue
trans-rectally or endoscopically. The system is configured to
deliver a heated vapor, for example water vapor, to tissue as
described in the following U.S. patent applications: Ser. No.
10/681,625, filed Oct. 7, 2003, now U.S. Pat. No. 7,674,259, titled
"Medical Instruments and Techniques for Thermally-Mediated
Therapies"; Ser. No. 11/158,930, filed Jun. 22, 2005, now U.S. Pat.
No. 7,892,229, titled "Medical Instruments and Techniques for
Treating Pulmonary Disorders"; Ser. No. 11/244,329, filed Oct. 5,
2005, now U.S. Pat. No. 8,016,823, titled "Medical Instrument and
Method of Use"; and Ser. No. 11/329,381, filed Jan. 10, 2006, now
U.S. Pat. No. 8,444,636, titled "Medical Instrument and Method of
Use".
The generation and delivery of a collapsible, high energy vapor for
various therapeutic procedures is further disclosed in systems with
"remote" vapor generation systems or sources in Provisional Patent
Application Nos. 60/929,632, 61/066,396, 61/068,049, or with vapor
generator in a handle or working end, or combination thereof, as
described in Provisional Application Nos. 61/068,130, 61/123,384,
61/123,412, 61/126,651, 61/126,612, 61/126,636, 61/126,620.
FIG. 1 illustrates a vapor energy generation system 800 having a
handle 802 comprising an inductive heating system similar to that
described in Provisional Application Nos. 61/123,416, 61/123,417,
and 61/126,647. In FIG. 1, the handle 802 is coupled by temperature
resistant fitting 806 to a fluid source 810 that delivers liquid at
a controlled flow rate and pressure. The liquid flow passes through
a vapor generating inductive heater 805 coupled to an electrical
source and controller 820. The system and handle is configured for
a looped liquid/vapor flow to provide vapor to working end or exit
channel 822 to deliver the vapor to a tissue site. The system has
inflow channel indicated at 824 and outflow channel at 826 that can
communicate with a collection reservoir 830 and/or a negative
pressure source 835. A valve 836, for example, operated by a
footswitch is provided in outflow channel 826 to re-direct vapor
into the exit channel 822 and extension member 840.
A vapor energy generation system 800 as shown in FIG. 1 can be used
for any surgical/medical application, with the extension member 840
comprising a needle, an elongate probe or flexible catheter and
other similar elongate delivery devices. This system can be used
for a catheter for delivering energy for endovascular applications,
for treating respiratory tract disorders, for endometrial ablation
treatments or for needle ablation treatments. In the embodiment of
FIG. 1, an optional secondary heater 845 is shown with a concentric
insulator 846. This secondary heater can add further vaporization
energy to vapor that starts to flow through exit channel 822. The
secondary heater can be an inductive heater or a resistive heater
that uses a microporous material to provide a large surface area to
apply energy to the vapor to remove any water droplets. This system
can provide a vapor that is at least 90% water vapor. The secondary
heater is operatively coupled to the electrical source and
controller 820 by electrical leads (not shown).
FIG. 2 illustrates a vapor generating inductive heater 805 that in
one embodiment comprises a ceramic cylinder 850 with a bore 852
therein. The ceramic cylinder 850 can be approximately 1.0'' to
1.5'' in length and 0.25'' in diameter with a 0.10'' bore 852, for
example. The bore 852 is packed with a plurality of small diameter
hypotubes 855 that are magnetic responsive, such as 316 stainless
steel, for example. In one embodiment, the hypotubes 855 are 0.016
thin wall tubes. A winding 860 of one to ten layers having an axial
length of about 1.0'' is provided about the ceramic cylinder 850
for inductive heating of the hypotubes 855 using very high
frequency current from an electrical source. In one embodiment the
winding 860 can be 26 Ga. Copper wire with a Teflon coating. It has
been found that delivering at least 50 W, 100 W, 200 W, 300 W, or
400 W with suitable flow rates of water can produce very high
quality vapor, for example 90% vapor and better.
In FIG. 2, it can be seen that an inductively heated hypotube 855'
also can be spiral cut to provide flexibility for such an inductive
heater to be positioned in a catheter or probe working end. For
example, such flexible heatable elements can be carried in the bore
of a flexible high temperature resistant polymeric insulative
member such to provide a flexible catheter that is configured for
endovascular navigation. An insulation layer about an exterior of
the inductive heater is not shown. In general, the vapor generating
inductive heater 805 can configured to provide a high quality
condensable vapor media with precise parameters in terms of vapor
quality, exit vapor pressure from a working end, exit vapor
temperature, and maintenance of the parameters within a tight range
over a treatment interval. All these parameters can be controlled
with a high level of precision to achieve controlled dosimetry,
whether the particular treatment calls for very low pressures
(e.g., 1-5 psi) or very high pressures (200 psi or greater) over a
treatment interval, and whether the treatment interval is in the
1-10 second range or 2 to 5 minute range.
Now turning to FIG. 3, a sectional schematic view of a patient
urethra 105 and prostate 106 is shown with an instrument shaft
navigated to a predetermined location in a patient urethra with an
imaging system (not shown) to identify anatomical landmarks. An
imaging system can be provided in the form of a scope in a channel
or a CCD. A system for volumetrically removing prostate tissue is
shown with FIG. 3 having an elongate tissue-extraction member 405
with a working end 410 advanced in a transurethral manner into the
interior of a patient prostate. The tissue regions indicated at
420A and 420B in the opposing lobes can be targeted for removal.
The system also can contemporaneously thermally seal of the margins
of the extracted tissue volumes. An irrigation system (not shown)
can be provided to supply a fluid to the lumen.
FIG. 4 illustrates that the tissue extraction member 405 and
working end 410 can be a rigid or slightly flexible assembly having
a diameter ranging from about 2 mm to 10 mm. The tissue extraction
member can include at least one vapor delivery port 444
communicating with a vapor source 100 and can be adapted to deliver
condensable vapor to the prostate lobe. The tissue extraction
member can also have at least one aspiration port 480 in
communication with a negative pressure source 470 and adapted to
aspirate prostate tissue proximally into the tissue extraction
member. In one embodiment, the tissue extraction member is
configured for jetting one of at least one fluid or vapor media
from source of liquid media 450, for applying mechanical energy and
thermal energy to interfacing tissue for ablation and volumetric
removal of urethral tissue and adjacent tissue in a TURP-like
procedure.
The working end can carry optional occlusion members 422a and 422b
that are expanded by a fluid inflation source 425. The occlusion
members can be positioned on the proximal and distal portions of
the tissue extracting member. The distal occlusion member 422b is
adapted to occlude the urethra distal to the vapor delivery port(s)
444, and the proximal occlusion member 422a is adapted to occlude
the urethra proximal to the vapor delivery port(s).
A central portion 430 of the working end is configured to rotate in
the body lumen. Rotation of the working end can be manual (e.g.,
physical rotation of the instrument by the physician) or,
alternatively, a rotating mechanism 186 (e.g., a powered rotating
motor) can be coupled to the working end 410 to automatically
rotate the distal end of the device during ablation and aspiration.
The rotating mechanism can be configured to rotate the ablation
probe between 5 rpm and 10,000 rpm, for example. Further details of
a method of rotating an ablation probe in tissue are described in
U.S. patent application Ser. Nos. 12/389,808 and 61/123,416, which
are incorporated herein by reference.
FIG. 5 shows a sectional view of the instrument working end 410,
where it can be seen that a first fluid flow system or condensable
vapor source 100 (for example, as shown in FIG. 1) is provided and
is fluidly coupled to at least one vapor inflow channel 452 that
extends to at least one vapor delivery port 444 in at least one
recess 445 in the working end. In this embodiment, the axis of each
vapor delivery port can be directed axially relative to the axis
448 of the instrument, or alternatively the axis can be directed
radially outwardly from the device axis 448 at an angle of between
about 10.degree. to 90.degree. relative to a longitudinal axis 448
of the tissue extraction member.
Still referring to FIG. 5, the instrument working end 410 includes
a second fluid flow system comprising a high pressure liquid source
450 that is fluidly coupled to at least one vapor inflow channel
440 that extends to at least one liquid ejection port 460 in at
least one recesses 445 in the working end. In this embodiment, the
axis of each liquid ejection port can be directed substantially
axially relative to the axis 448 of the instrument, or
alternatively the axis can be directed radially outwardly from the
device axis at an angle of between about 10.degree. to 90.degree.
relative to a longitudinal axis 448 of the tissue extraction
member.
As can be seen in FIG. 5, the instrument working end 410 further
includes a tissue extraction channel 465 coupled a negative
pressure source 470 for extracting disintegrated tissue, water and
condensed vapor media from the treatment site. A computer
controller 475 is operatively coupled to the various systems and
sources 100, 450 and 470 to allow operation in unison.
Referring to FIG. 5, the instrument working end 410 can actuate the
aspiration or negative pressure source 470 and controller 475 to
suction tissue into the working end recesses 445 and aspiration
port 480, wherein in rotational operation, it can be understood
that high pressure ejection of vapor from outlets 444 will cause
thermal damage, weakening and denaturation of proteins and tissue
constituents. At the same time, the high pressure ejection of
liquid media from outlets 460 can disintegrate and disrupt the
thermally damaged and weakened tissue to allow its extraction
through ports 480. At the same time, the vapor flow and phase
change energy release thereof contemporaneously seals or coagulates
the tissue margins to prevent bleeding. Following the treatment,
the body's wound healing response will heal the urethra as is
common in TURP procedures.
It should be appreciated that the working end can have one or more
structures for fluid ejection to extract tissue, and can be
actuated rotationally and or axially. In one embodiment, the system
can be configured to apply energy to tissue about only a selected
radial angle of the tissue, for example 5.degree., 15.degree.,
30.degree., 45.degree., 60.degree., 90.degree. or 180.degree. of
the lumen. Similarly, the tissue ablation and extraction can have
any axial orientation, for example to ablate and extract linear
portions of tissue.
In another method, the working end as in FIGS. 4-5 can be provided
without balloons and can be introduced interstitially to extract
cores of prostatic tissue.
In another embodiment, a single fluid injection port can be
utilized wherein the vapor quality is such that vapor and water
droplets in the same flow can apply sufficient mechanical forces to
disintegrate and volumetrically remove tissue at the vapor-tissue
interface. Thus, in one aspect of the invention, the quality of the
vapor, or combination of jetted vapor with jetted water droplets
can cut the thermally weakened tissue. In another method, the fluid
jet is pulsed at a rate of 1 to 100 pulses/second. In another
embodiment, the fluid jetting is pulsed with intermittent pulses of
water and vapor at a high repetition rate with the jetted water
aliquot capable of disintegrating tissue and the vapor aliquot
configured to weaken tissue and thermally seal tissue.
FIG. 6 illustrates another embodiment of working surface portion
wherein a vapor delivery port 490 is concentric around a liquid
ejection port 495 for interacting with and ablating tissue. The
outlets can be configured is any type of surface structure for
ablating tissue such as the recesses of the working end of FIGS. 4
and 5.
In general, a method for treating a prostate disorder comprises
volumetrically removing urethra and surrounding prostatic tissue in
a method performed with the ejection of jetted liquid and a heated
condensable vapor from a device working end together with
aspiration of the disintegrated tissue. In one aspect of the
invention, the ejection of vapor media applies sufficient thermal
energy to substantially modify tissue, wherein the modification
consists of at least one of weakening covalent bonds, denaturing
proteins and disrupting collagen structures. Further, the ejection
of liquid media applies sufficient mechanical energy for tissue
removal wherein removal consists of at least one of disintegrating,
cutting, excising and ablating tissue. In another aspect of the
invention, the ejection of vapor media applies sufficient thermal
energy to heat seal or coagulate margins around the extracted
tissue. Also, the methods of volumetrically removing tissue can be
is performed contemporaneous with imaging, such as ultrasound
imaging.
In general, a method for sealing the tissue extracted tissue
margins is accomplished with the injecting condensable vapor media
from a device working end and aspiration of the disintegrated
tissue wherein the energy from the vapor comprises delivering at
least 100 W, 250 W, 500 W, and 1000 W to the tissue. In another
embodiment, injecting condensable vapor comprises delivering
between 100 cal/gram and 600 cal/gram to the prostate.
In general, the method for treating a BPH can volumetrically remove
prostatic tissue equaling at least 1 gram, 10 grams, at least 20
grams, at least 30 grams, at least 40 grams, at least 50 grams, and
at least 100 grams of tissue.
One embodiment of a method of extracting tissue from a patient's
prostate comprises introducing a tissue extraction member into a
urethra of the patient, rotating the tissue extraction member
within the urethra, injecting condensable vapor from the tissue
extraction member, and aspirating prostate tissue into the tissue
extraction member. The rotating step can comprise rotating the
tissue extraction member between 5 rpm and 10,000 rpm, such as with
a powered rotating motor, for example. In another embodiment, the
tissue extraction member can be manually rotated.
The method can further comprise injecting high pressure liquid from
the tissue extraction member into the urethra. Injection of the
high pressure liquid can be injected in pulses between 1
pulse/second and 100 pulses/second. In some embodiments, the high
pressure liquid can be injected radially outward from a
longitudinal axis of the tissue extraction member. In other
embodiments, the high pressure liquid can be injected at an angle
between 10 degrees and 90 degrees from a longitudinal axis of the
tissue extraction member.
In some embodiments of the method, an occlusion member is expanded
within the urethra distal to a tissue extraction member vapor exit
port. This step can be performed before injecting condensable vapor
from the tissue extraction member, for example. In another
embodiment, an occlusion member is expanded within the urethra
proximal to a tissue extraction member vapor exit port. This step
can be performed before injecting condensable vapor from the tissue
extraction member, for example.
In another embodiment, a high speed rotational cutter can be used
contemporaneous with a vapor ejection as described above to
thermally coagulate the margins about the removed tissue.
A system of the invention comprises an elongated tissue extraction
member with a working end configured for removing urethral tissue
in a patient prostate, a vapor source in fluid communication with
vapor delivery ports in the distal end, a liquid jetting source for
ejecting high pressure liquid form the working end and a negative
pressure source coupled to a channel in fluid communication with a
tissue aspiration port in the working end proximate the vapor
delivery ports. The port(s) can be oriented distally relative to an
axis of the tissue extraction member, or at an angle relative to an
axis of the tissue extraction member, or oriented at a side of
tissue extraction member substantially parallel to the axis of the
tissue extraction member.
In general, the methods of the invention include delivery of a
condensable vapor that undergoes a phase change to provide applied
energy of at least 100 cal/gm, 250 cal/gm, 300 cal/gm, 350 cal/gm,
400 cal/gm, 450 cal/gm, and 600 cal/gm of the vapor.
In another aspect of the invention, the treatment with vapor can be
accomplished under any suitable type of imaging. In one method, the
steps can be viewed by means of ultrasound or x-ray imaging. In one
method, the introducer and energy delivery methods of the invention
can be imaged by ultrasound utilizing a trans-rectal ultrasound
system.
In another aspect of the invention, the system may
contemporaneously be used to deliver fluids to targeted locations
in the prostate for medical purposes, such as for general or
localized drug delivery, chemotherapy, or injections of other
agents that may be activated by vapor or heat.
Although particular embodiments of the present invention have been
described above in detail, it will be understood that this
description is merely for purposes of illustration and the above
description of the invention is not exhaustive. Specific features
of the invention are shown in some drawings and not in others, and
this is for convenience only and any feature may be combined with
another in accordance with the invention. A number of variations
and alternatives will be apparent to one having ordinary skills in
the art. Such alternatives and variations are intended to be
included within the scope of the claims. Particular features that
are presented in dependent claims can be combined and fall within
the scope of the invention. The invention also encompasses
embodiments as if dependent claims were alternatively written in a
multiple dependent claim format with reference to other independent
claims.
* * * * *
References